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Background Single-dose vaccination was widely recommended in the pre-Omicron era for persons with previous SARS-CoV-2 infection. The effectiveness of a second vaccine dose in this group in the Omicron era is unknown. Methods We linked nationwide population registries in Spain to identify community-dwelling individuals aged 18–64, with a positive SARS-CoV-2 test before single-dose mRNA vaccination (mRNA-1273 or BNT162b2). Every day between 3 January and 6 February 2022 we matched 1:1 individuals receiving a second mRNA vaccine dose and controls on sex, age, province, first dose type and time, month of primary infection, and number of previous tests. We then estimated Kaplan–Meier risks of confirmed SARS-CoV-2 reinfection. We performed a similar analysis in a Delta-dominant period, between 19 July and 30 November 2021. Results In the Omicron period, estimated effectiveness (95% CI) of a second dose was 62.2% (58.2–66.4%) 7–34 days after administration, similar across groups defined by age, sex, type of first vaccine, and time since the first dose. Estimated effectiveness was 65.4% (61.1–69.9%) for mRNA-1273 and 52.0% (41.8–63.1%) for BNT162b2. Estimated effectiveness was 78.5% (67.4–89.9%), 66.1% (54.9–77.5%), and 60.2% (55.5–64.8%) when primary infection had occurred in the Delta, Alpha, and pre-Alpha periods, respectively. In the Delta period, the estimated effectiveness of a second dose was 8.8% (−55.3% to 81.1%). Conclusions Our results suggest that, over 1 month after administration, a second dose of mRNA vaccine increases protection against SARS-CoV-2 reinfection with the Omicron variant among individuals with single-dose vaccination and previously infected with another variant.

We conducted a registries-based cohort study of long-term care facility residents >65 years of age offered vaccination against severe acute respiratory syndrome coronavirus 2 before March 10, 2021, in Spain. Risk for infection in vaccinated and nonvaccinated persons was compared with risk in the same persons in a period before the vaccination campaign, adjusted by daily-varying incidence and reproduction number. We selected 299,209 persons; 99.0% had >1 dose, 92.6% had 2 doses, and 99.8% of vaccines were Pfizer/BioNTech (BNT162b2). For vaccinated persons with no previous infection, vaccine effectiveness was 81.8% (95% CI 81.0%-82.7%), and 11.6 (95% CI 11.3-11.9) cases were prevented per 10,000 vaccinated/day. In those with previous infection, effectiveness was 56.8% (95% CI 47.1%-67.7%). In nonvaccinated residents with no previous infection, risk decreased by up to 81.4% (95% CI 73.3%-90.3%). Our results confirm vaccine effectiveness in this population and suggest indirect protection in nonvaccinated persons. Sí

I-MOVE-COVID-19 study team: Esther Kissling, Lisa Domegan, Joan O’Donnell, Josephine Murray, Virginia Sandonis Martín, Iván Martínez-Baz, Ausenda Machado, Itziar Casado, Sylvie Behillil, Amparo Larrauri, Ruby Tsang, Marit de Lange, Maximilian Riess, Jesús Castilla, Mark Hamilton, Alessandra Falchi, Francisco Pozo, Linda Dunford, Cristina Burgui, Debbie Sigerson, Thierry Blanchon, Eva María Martínez Ochoa, Jeff Connell, Joanna Ellis, Rianne van Gageldonk-Lafeber, Irina Kislaya, Angela MC Rose, Jamie Lopez Bernal, Nick Andrews, Inmaculada Casas Flecha, Janine Thoulass, Baltazar Nunes, Verónica Gomez, Rita Sa Machado, Vincent Enouf, Pedro Licinio Pinto Leite, Anna Molesworth, Adele McKenna, Janine Thoulass As the COVID-19 pandemic began in early 2020, primary care influenza sentinel surveillance networks within the Influenza - Monitoring Vaccine Effectiveness in Europe (I-MOVE) consortium rapidly adapted to COVID-19 surveillance. This study maps system adaptations and lessons learned about aligning influenza and COVID-19 surveillance following ECDC / WHO/Europe recommendations and preparing for other diseases possibly emerging in the future. Using a qualitative approach, we describe the adaptations of seven sentinel sites in five European Union countries and the United Kingdom during the first pandemic phase (March–September 2020). Adaptations to sentinel systems were substantial (2/7 sites), moderate (2/7) or minor (3/7 sites). Most adaptations encompassed patient referral and sample collection pathways, laboratory testing and data collection. Strengths included established networks of primary care providers, highly qualified testing laboratories and stakeholder commitments. One challenge was the decreasing number of samples due to altered patient pathways. Lessons learned included flexibility establishing new routines and new laboratory testing. To enable simultaneous sentinel surveillance of influenza and COVID-19, experiences of the sentinel sites and testing infrastructure should be considered. The contradicting aims of rapid case finding and contact tracing, which are needed for control during a pandemic and regular surveillance, should be carefully balanced. This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 101003673. info:eu-repo/semantics/publishedVersion

Introduction In July and August 2021, the SARS-CoV-2 Delta variant dominated in Europe. Aim Using a multicentre test-negative study, we measured COVID-19 vaccine effectiveness (VE) against symptomatic infection. Methods Individuals with COVID-19 or acute respiratory symptoms at primary care/community level in 10 European countries were tested for SARS-CoV-2. We measured complete primary course overall VE by vaccine brand and by time since vaccination. Results Overall VE was 74% (95% CI: 69–79), 76% (95% CI: 71–80), 63% (95% CI: 48–75) and 63% (95% CI: 16–83) among those aged 30–44, 45–59, 60–74 and ≥ 75 years, respectively. VE among those aged 30–59 years was 78% (95% CI: 75–81), 66% (95% CI: 58–73), 91% (95% CI: 87–94) and 52% (95% CI: 40–61), for Comirnaty, Vaxzevria, Spikevax and COVID-19 Vaccine Janssen, respectively. VE among people 60 years and older was 67% (95% CI: 52–77), 65% (95% CI: 48–76) and 83% (95% CI: 64–92) for Comirnaty, Vaxzevria and Spikevax, respectively. Comirnaty VE among those aged 30–59 years was 87% (95% CI: 83–89) at 14–29 days and 65% (95% CI: 56–71%) at ≥ 90 days between vaccination and onset of symptoms. Conclusions VE against symptomatic infection with the SARS-CoV-2 Delta variant varied among brands, ranging from 52% to 91%. While some waning of the vaccine effect may be present (sample size limited this analysis to only Comirnaty), protection was 65% at 90 days or more between vaccination and onset.

Background: The first signal of a new infection is often severe cases presenting at hospital. Enhanced surveillance of these cases is critical to learning more about disease epidemiology and patient outcomes, but nationallevel surveillance can lack power to draw conclusions. In response to the emergence of SARS-CoV-2, the Influenza-Monitoring Vaccine Effectiveness (I-MOVE) network, founded in 2007, expanded to establish the I-MOVE-COVID-19 Consortium in February 2020. The Consortium’s surveillance objectives included using pooled data to describe clinical and epidemiological characteristics of hospitalised COVID-19 patients across Europe, in order to contribute to the knowledge base, guide patient management, and inform public health response. Methods: Eleven study sites participated in the surveillance, including 23 hospitals across six EU Member States and Albania, and hospitals nationally in England and Scotland. A standardised protocol and dataset for collection was agreed by April 2020. In England and Scotland, data were generated by linkage of routine datasets; other sites used bespoke paper or electronic questionnaires. Data were submitted, pooled and analysed quarterly. Results: Data were received regarding 84,297 COVID-19 patients hospitalised between 1 February 2020 and 31 January 2021. Three surveillance bulletins were published between September 2020 and March 2021, providing key insights into severe COVID-19 at European level. However, the unexpected, overwhelming workload at participating sites, and difficulties securing data protection and ethics permissions, delayed data submissions and presented challenges for timely analysis. Conclusions: Building on an existing network facilitated a novel European multicentre hospital surveillance system to be implemented during a pandemic; however, timeliness was nonetheless problematic. In future, processes could be streamlined e.g. by developing pre-approved template protocols with information governance and ethical approvals in place during the inter- pandemic period. The I-MOVE-COVID-19 network has received funding from the European Commission (from the European Union’s Horizon 2020 research and innovation programme under grant agreement no. 101003673). N/A

Background: The I-MOVE-COVID-19 Consortium was established to conduct surveillance of hospitalised COVID-19 cases in nine European countries, aiming to describe the clinical and epidemiological characteristics of severe COVID-19 in order to inform public health response. Methods: Data are pooled from 11 participating sites; two (England and Scotland) submitting national data, with the remainder being from a selection of hospitals. Descriptive analysis is performed on the pooled dataset overall and comparing data on patients admitted from week 5 to 28 of 2020 (“first wave”) vs those admitted later (“second wave”). Results: Data on 84,297 hospitalised patients were submitted for 01 February 2020 - 31 January 2021. Fifty-six percent of cases (46,907/84,193) were male and median age was 69 years. Where information was available, 44% (25,344 /57,769) patients were recorded as having at least one chronic condition. Ninety-five percent (7,868/8,270 and 90% (5,606/6,231) were reported with respiratory and febrile presentations respectively. Twenty-four percent (18,795/78,955) were admitted to intensive care units (ICU) and 26% (19,805/76,764) died in hospital (all sites); 12% (3,305/28,262) and 20% (5,454/27,066) respectively for all sites except England (where ICU reporting is mandated, biasing the dataset towards more severe outcomes as this site represents >50% of all cases). As a percentage of all hospital admissions, both ICU admissions and deaths decreased significantly between the first and second waves in both sexes and across all age- groups, apart from the over 75s. Conclusions: Results from this multicentre European surveillance system suggest that about one in 10 hospitalised COVID-19 patients are admitted to ICU and one in five have fatal outcomes. Fatality and ICU admission were lower in the second wave compared with the first. The I-MOVE-COVID-19 network has received funding from the European Commission (from the European Union’s Horizon 2020 research and innovation programme under grant agreement no. 101003673). N/A

I-MOVE-COVID-19 primary care study team (in addition to authors above): Nick Andrews, Jamie Lopez Bernal, Heather Whitaker, Caroline Guerrisi, Titouan Launay, Shirley Masse, Sylvie van der Werf, Vincent Enouf, John Cuddihy, Adele McKenna, Michael Joyce, Cillian de Gascun, Joanne Moran, Ana Miqueleiz, Ana Navascués, Camino Trobajo-Sanmartín, Carmen Ezpeleta, Paula López Moreno, Javier Gorricho, Eva Ardanaz, Fernando Baigorria, Aurelio Barricarte, Enrique de la Cruz, Nerea Egüés, Manuel García Cenoz, Marcela Guevara, Conchi Moreno-Iribas, Carmen Sayón, Verónica Gomez, Baltazar Nunes, Rita Roquete, Adriana Silva, Aryse Melo, Inês Costa, Nuno Verdasca, Patrícia Conde, Diogo FP Marques, Anna Molesworth, Leanne Quinn, Miranda Leyton, Selin Campbell, Janine Thoulass, Jim McMenamin, Ana Martínez Mateo, Luca Basile, Daniel Castrillejo, Carmen Quiñones Rubio, Concepción Delgado-Sanz, Jesús Oliva. The I-MOVE-COVID-19 network collates epidemiological and clinical information on patients with coronavirus disease (COVID-19), including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virological characterisation in 11 European countries [1]. One component of I-MOVE-COVID-19 is the multicentre vaccine effectiveness (VE) study at primary care/outpatient level in nine European study sites in eight countries. We measured overall and product-specific COVID-19 VE against symptomatic SARS-CoV-2 infection among those aged 65 years and older. We also measured VE by time since vaccination. This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 101003673. info:eu-repo/semantics/publishedVersion

A remarkable excess mortality has coincided with the COVID-19 pandemic in Europe. We present preliminary pooled estimates of all-cause mortality for 24 European countries/federal states participating in the European monitoring of excess mortality for public health action (EuroMOMO) network, for the period March-April 2020. Excess mortality particularly affected ≥ 65 year olds (91% of all excess deaths), but also 45-64 (8%) and 15-44 year olds (1%). No excess mortality was observed in 0-14 year olds. he EuroMOMO network has received financial support from the European Centre for Disease Prevention and Control (ECDC) and from the World Health Organization (WHO) Regional Office for Europe. We acknowledge all EuroMOMO partners for their contributions as well as the various National Offices of Statistics that are essential partners in ensuring the ongoing monitoring of mortality across Europe. Sí

Background The first wave of the coronavirus disease (COVID-19) pandemic spread rapidly in Spain, one of Europe’s most affected countries. A national lockdown was implemented on 15 March 2020. Aim To describe reported cases and the impact of national lockdown, and to identify disease severity risk factors. Methods National surveillance data were used to describe PCR-confirmed cases as at 27 April 2020. We compared case characteristics by severity categories (hospitalisation, admission to intensive care unit (ICU), death) and identified severity risk factors using multivariable regression. Results The epidemic peaked on 20 March. Of 218,652 COVID-19 cases, 45.4% were hospitalised, 4.6% were admitted to ICU and 11.9% died. Among those who died, 94.8% had at least one underlying disease. Healthcare workers (HCWs) represented 22.9% of cases. Males were more likely to have severe outcomes than females. Cardiovascular disease was a consistent risk factor. Patients with pneumonia had higher odds of hospitalisation (odds ratio (OR): 26.63; 95% confidence interval (CI): 25.03–28.33). The strongest predictor of death was age ≥ 80 years (OR: 28.4; 95% CI: 19.85–40.78). Among underlying diseases, chronic renal disease had highest odds of death (OR: 1.47; 95% CI: 1.29–1.68). Conclusions COVID-19 case numbers began declining 6 days after the national lockdown. The first wave of the COVID-19 pandemic in Spain had a severe impact on elderly people. Patients with cardiovascular or renal conditions were at higher risk for severe outcomes. A high proportion of cases were HCWs. Enhanced surveillance and control measures in these subgroups are crucial during future COVID-19 waves.

BackgroundTo increase the acceptability of influenza vaccine, it is important to quantify the overall benefits of the vaccination programme.AimTo assess the impact of influenza vaccination in Portugal, Spain and the Netherlands, we estimated the number of medically attended influenza-confirmed cases (MAICC) in primary care averted in the seasons 2015/16 to 2017/18 among those ≥ 65 years.MethodsWe used an ecological approach to estimate vaccination impact. We compared the number of observed MAICC (n) to the estimated number that would have occurred without the vaccination programme (N). To estimate N, we used: (i) MAICC estimated from influenza surveillance systems, (ii) vaccine coverage, (iii) pooled (sub)type-specific influenza vaccine effectiveness estimates for seasons 2015/16 to 2017/18, weighted by the proportion of virus circulation in each season and country. We estimated the number of MAICC averted (NAE) and the prevented fraction (PF) by the vaccination programme.ResultsThe annual average of NAE in the population ≥ 65 years was 33, 58 and 204 MAICC per 100,000 in Portugal, Spain and the Netherlands, respectively. On average, influenza vaccination prevented 10.7%, 10.9% and 14.2% of potential influenza MAICC each season in these countries. The lowest PF was in 2016/17 (4.9-6.1%) with an NAE ranging from 24 to 69 per 100,000.ConclusionsOur results suggest that influenza vaccination programmes reduced a substantial number of MAICC. Together with studies on hospitalisations and deaths averted by influenza vaccination programmes, this will contribute to the evaluation of the impact of vaccination strategies and strengthen public health communication. publishersversion published

Background: In a context of lower than targeted influenza vaccination (IV) coverage, identifying factors associated IV uptake is essential to improve population coverage. Although extensive work has been done in this field, scarcer studies focused on framing these factors within a multifactorial model. Having the social ecological model (SEM) as framework, this study intended to identify and quantify the SEM levels associated to seasonal IV uptake in the Portuguese population aged 65 and more years. Methods: Data from the Portuguese 2014 National Health Survey was restricted to individuals aged 65 and more years (n=5669). The outcome of interest was self-reported IV uptake in the 2 years previous to the interview. Twenty three independent variables were selected from the survey and were allocated in one of the five SEM levels: individual, interpersonal, organizational, community and policy. Sex stratified and age adjusted analysis using Poisson regression were performed for each SEM level. To evaluate statistical significance and marginal contribution of each SEM level for explaining IV uptake, the full model was fitted (all variables from all 5 SEM levels). To determine joint statistical significance of variables of each SEM level, the model without respective SEM level was compared with the full model using likelihood ratio test. Additionally, marginal contribution of each SEM level was measured by relative reduction in magnitude of pseudo R square. Results: For both men and women, older age groups (85 or more vs 65-69 age group; PR=1.59 for men and PR=1.56 for women); having 3 or more chronic conditions (PR=1.39 for men and PR=1.35 for women); number of GP and outpatient visits in the previous 4 weeks were associated to higher IV uptake. For men, only 2 out of the 5 SEM levels were associated to IV uptake (individual and organizational). For women 3 levels were relevant for this preventive measure (individual, organizational and community). Main marginal contribution for explaining the IV uptake, came from individual (17.9% and 16.3%) and organizational (30.7% and 22.7%) levels for both men and women respectively. Conclusions: Besides individual characteristics, like age and health status - known determinants of IV uptake - this study highlights the importance of access and use of health care services for adoption of IV preventive measure. Moreover, it evidences a sex differential behaviour that should be accounted in the definition of the IV campaign strategy. N/A

Introduction / Objectives: Influenza has a considerable impact on mortality. Significant excess all-cause mortality is often observed during winter seasons, mainly among the elderly. Quantifying the mortality associated to influenza is important to estimate the real impact of seasonal influenza epidemics on the population. Our objective is to estimate the influenza-attributable mortality in Portugal and Spain for seasons 2012-13 to 2017-18 Methodology: To estimate influenza-attributable mortality in both countries, a multiplicative Poisson regression time-series model (FluMOMO) with over-dispersion corrected for trend and seasonality, with ISO-week as time unit was used. We estimated influenza-attributable deaths and mortality rates (and their 95% CIs), for all ages and by age group (

Results of previous influenza vaccination effects on current season influenza vaccine effectiveness (VE) are inconsistent.